Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics – Current challenges and approaches

Autor: Broschard, Thomas H., Glowienke, Susanne, Bruen, Uma S., Nagao, Lee M., Teasdale, Andrew, Stults, Cheryl L.M., Li, Kim L., Iciek, Laurie A., Erexson, Greg, Martin, Elizabeth A., Ball, Douglas J.
Zdroj: In Regulatory Toxicology and Pharmacology November 2016 81:201-211
Databáze: ScienceDirect